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Statin Label Change Stirs OTC Switch Discussions

 
• By Malcolm Spicer

FDA eliminates the label statement that liver function tests should be performed prior to and at 12 weeks following therapy or dose elevation, and periodically thereafter. A study design expert predicts better chances for a statin switch, but a consumer health advocate doubts nonprescription access will be safe.

FDA’s easing of liver monitoring requirements for statins leads a clinical study design expert to predict a better chance of success for switching cholesterol-lowering drugs like Pfizer Inc.’s Lipitor OTC, but some say the change won’t improve the odds for a statin switch.

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• By Sarah Karlin-Smith

FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.

Another Regeneron CRL Prompts Regulatory Operations Questions

 
• By Alaric DeArment

CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.